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FDA 510(k)

SERIES 9600 MOBILE DIGITAL IMAGING SYSTEM

K-Number: K963952 · 1996-12-23

ApplicantGe Dec Medical Systems
Decision Date1996-12-23
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SERIES 9600 MOBILE DIGITAL IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ge Dec Medical Systems. It received FDA 510(k) clearance on 1996-12-23 under 510(k) number K963952. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERIES 9600 MOBILE DIGITAL IMAGING SYSTEM?

SERIES 9600 MOBILE DIGITAL IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1996-12-23. The listed applicant is Ge Dec Medical Systems. The 510(k) number is K963952.

When did SERIES 9600 MOBILE DIGITAL IMAGING SYSTEM receive FDA 510(k) clearance?

SERIES 9600 MOBILE DIGITAL IMAGING SYSTEM received FDA 510(k) clearance on 1996-12-23, under 510(k) number K963952.

Who is the listed applicant for SERIES 9600 MOBILE DIGITAL IMAGING SYSTEM?

The FDA 510(k) record lists Ge Dec Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SERIES 9600 MOBILE DIGITAL IMAGING SYSTEM?

The FDA product code for SERIES 9600 MOBILE DIGITAL IMAGING SYSTEM is OWB.

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Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Ge Dec Medical Systems as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K000221SERIES 7700 MOBILE C-ARM, COMPACT 7700 MOBILE C-ARM, COMPACT 7700 PLUS MOBILE C-ARMK993687UROVIEW 2800K992506MINI 6800 DIGITAL MOBILE C-ARMK974355INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS)K970063SERIES 7600 MOBILE DIGITAL C-ARMK950781COMPACT 7600

View all 10 devices →

Related Devices (Code: OWB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.K261413EXTRON 3;EXTRON 6DRTECH CorporationK254205Zenition 30Philips Medical Systems Nederland B.V.K260607Shield System (Siemens 30x40)Radiaction , Ltd.K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.K252735C-beamPulmera, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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